Pioneer Packaging Worldwide’s outlook is Imagine it . . . Done. That’s not just our motto—it’s also our mindset for every project we take on. It is this mindset that makes Pioneer Packaging Worldwide a leader in the design and manufacturing of custom packaging solutions. We’ve been engineering innovative packaging answers for clients in the medical, industrial, retail, and moving and storage industries for more than 35 years. We work with all of our clients to create cutting-edge packaging that reflects the quality of their business. We offer state-of-the-art facilities to partner with clients in every step of the packaging process, from packaging design to manufacturing to fulfillment and storage. Our in-depth packaging industry expertise combined with a partnership approach allows us to customize the perfect packaging solution for any client, large or small. One of our specialty packaging areas is producing high-quality medical packaging—an arena that offers special challenges that other fields don’t. We understand the importance of maintaining product sterility and integrity in medical packaging and are able to leverage our considerable expertise to provide a wide array of packaging solutions to the medical industry. Our medical packaging team specializes in using innovative solutions to create packaging that will meet the rigorous quality requirements of the industry and still be cost-effective, always using the highest quality materials to ensure protection and reliability. We always strive to stay current on the latest trends in medical packaging, so we can meet our promise of providing clients with affordable, cutting-edge solutions in the medical field. Here are some of the issues the medical packaging industry is facing.
Using packaging to deal with America’s opioid crisis. As we try to get a handle on what has become an epidemic, we’ve come together as a nation to deal with it. It turns out that packaging may be a secret weapon for dealing with opioids. In May of this year, the Food and Drug Administration (FDA) requested feedback from the public on a proposal that mandates certain opioids be packaged in fixed-quantity, unit-dose blisters. This is just the latest salvo in what is known as the SUPPORT law. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act was enacted about a year ago, on a near-unanimous vote in the United States House of Representatives (on a vote of 393 to 3) and the United States Senate (by a 98 to 1 vote) and is aimed squarely at the opioid crisis, utilizing a multi-pronged approach. According to Walter Berghahn, executive director for the Healthcare Compliance Packaging Council, a not-for-profit trade association that advocates for greater use of unit dose and compliance packaging formats in the United States, opioid manufacturers aren’t necessarily supportive of new packaging options that are designed to help prevent an opioid overdose. “In the last meeting I attended with FDA present, opioid manufacturers were pushing back on FDA and the requirement for blisters for initial (acute care) scrips. They were claiming that the tooling up to produce this form would be burdensome. They were concerned about blister capacity. They also felt that the number of forms that could be required—three day, five day, seven day—could create problems,” he said.
Berghahn continued, “The system as designed allows for the repackaging of pharmaceuticals in the pharmacy, an antiquated practice that has existed since the time when most pharmacies were compounding medications and hence packaging as well. No other country in the world repackages pharmaceuticals to the level that we do in the U.S. Other countries almost exclusively use the manufacturer’s package whether bottle or blister,” he said, adding, “The other packaging challenge would be that the blisters, in this case, would be F-1 CR according to CPSC [Consumer Product Safety Commission] guidance. The F-1 CR package is certainly a bit more complicated to produce but is readily available in numerous forms.”
Berghahn went on to explain how he believes unit-dose packaging helps curb the scourge of opioid abuse. “The concept behind the SUPPORT legislation is to reduce the excess supply of product in the market due to poor prescribing practices. Today, most scrips, due to insurance formulary, are written for 30 days. The healthcare community has come to the realization that this practice—which is fine for chronic treatment prescriptions—does not work so well for short-term acute-care events,” he said, adding, “Tooth extraction, a sprained ankle and such might require three to four days of opioids, but certainly not 30. The left-over doses are ripe for abuse, whether by the prescribed patient or by others in the household. They are all too frequently sold on the black market, as well.”
He believes there are other advantages to this kind of medical packaging. “The other benefit that packaging could provide, especially F-1 compliance packs, is to give visual reminders to patient and caregivers of doses taken. This can help in two ways: First, to help the patient avoid accidental overdosing, through better logging of doses taken and timing,” Berghahn said, continuing, “Second, it can provide visual evidence of pilfered doses. When doses go missing from a blister card, it is much easier to track than in a bottle where one would literally need to dump out the contents and count to verify that some are gone.” He wrapped things up on a hopeful note by saying, “If we take it a step further, smart packaging with integrated electronic chips/RFID could track doses taken and provide a warning to a caregiver in case of attempted overdose or pilferage.”
Can taking the brakes off of innovation help the medical packaging industry? Production executives in the pharmaceutical packaging industry have spoken of what they term “innovation inertia”—a tendency to slow down innovation, due to red tape and the imposition of legal hurdles, such as long approval times and short patent lives. In a recent report, Girish Malhotra dealt with this topic head-on. He is the president of Epcot International, an Ohio-based consultancy firm that specializes in manufacturing and technology simplification for pharmaceutical and other industries. “The problem we have presently is that, for manufacturing technology innovations to be successful, pharma companies (brand and generics) need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators—in particular the FDA [Food and Drug Administration]—are still dictating approaches to the industry without asking what the commercial justifications are to support them,” he stated.
Malhotra also wonders if recommendations are developed by regulators without any first-hand experience in the development, design, commercialization, and operation of pharmaceutical manufacturing facilities. He cautions that if this type of dictating doesn’t come to an end, advances in the manufacturing process might never occur. He adds that current guidelines for Good Manufacturing Practices (cGMP) force pharmaceutical companies to spend their time focusing on adhering to regulations, rather than being innovative. He believes that going down two paths—shortening the times for regulatory approval times and working closely with contract services worldwide—will spark a new, golden era of innovation and drug affordability for those pharmaceutical companies that produce patented products. He also thinks if the industry focuses on doing these two things, two good things will happen: drug shortages will decrease and companies will make more profits, without having to compromise product quality and safety.
“Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term, however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation. But my fear is that we are still at least three years away from this,” Malhotra concludes.
At Pioneer Packaging Worldwide, we know how crucial it is for medical merchandise to be sterile and made with the highest integrity. For the reputation of your business, medical packaging has to adhere to the utmost of standards, meeting and exceeding industry expectations. With our significant experience and team of experts, we have innovated solutions to meet the rigorous requirements of the industry. You can rely on Pioneer to offer the highest quality cost-effective medical packaging options. We produce all different types of sterile barrier pouch systems, as well as custom medical trays, lid products, and other pharmaceutical products. Pioneer offers cutting-edge solutions designed to increase productivity in the medical manufacturing environment.
We strive to deliver efficient, cost-effective medical packaging answers, offering automation solutions designed specifically for increasing productivity in the medical manufacturing environment. Using advanced technology and efficient packaging procedures, we provide clients with medical device and medical product packaging services designed to keep costs down and meet the stringent medical packaging industry standards.
Here are the medical packaging items Pioneer offers:
Custom Sterile Barrier Pouch Systems
- Medical Poly Bags
- Header Bags
- Chevron Design Pouches
- Linear Tear Packaging
- Tubing and high barrier foil lidding
- Heat sealable and sterilizable pouches
Custom Medical Tray and Lid Products
- Custom thermoformed medical trays
- Custom die cut lid stock with printing
To learn more about Pioneer’s time-tested, real-world approach to meet your medical packaging needs, contact us today.